NCT06433011

The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Thrombolex, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).

Detailed description

The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	The Bashir™ Endovascular Catheter	The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
DRUG	r-tPA	Pulse spray and infusion

Timeline

• Start date: 2024-06-25
• Primary completion: 2027-06-25
• Completion: 2027-08-25
• First posted: 2024-05-29
• Last updated: 2024-05-29

Regulatory

• FDA-regulated device study